Article

Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) showed a manageable and acceptable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-), high-risk, early breast cancer breast cancer.

Major finding: Grade ≥3 adverse events (AE) were more frequent in the abemaciclib+ET vs. ET alone arm (49.7% vs. 16.3%); however, neutropenia, the most frequent grade ≥3 AE, was manageable with dose modification. The discontinuation of abemaciclib and abemaciclib+ET due to AE occurred in 18.5% and 6.5% of patients, respectively, with 66.8% discontinuing abemaciclib because of grade 1/2 AE and <1% because of neutropenia, increased transaminase, interstitial lung disease, or venous thromboembolism.

Study details: Findings are from a safety analysis of the phase 3 monarchE study including 5591 patients with HR+/HER2-, node-positive, high-risk, early breast cancer who received ≥1 dose of abemaciclib+ET or ET alone in the adjuvant setting.

Disclosures: This study was supported by Eli Lilly and Company. Six authors declared being employees or shareholders of Eli Lilly and other authors reported ties with various sources, including Eli Lilly.

Source: Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 (Mar 22). Doi: 10.1016/j.annonc.2022.03.006

Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) showed a manageable and acceptable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-), high-risk, early breast cancer breast cancer.

Major finding: Grade ≥3 adverse events (AE) were more frequent in the abemaciclib+ET vs. ET alone arm (49.7% vs. 16.3%); however, neutropenia, the most frequent grade ≥3 AE, was manageable with dose modification. The discontinuation of abemaciclib and abemaciclib+ET due to AE occurred in 18.5% and 6.5% of patients, respectively, with 66.8% discontinuing abemaciclib because of grade 1/2 AE and <1% because of neutropenia, increased transaminase, interstitial lung disease, or venous thromboembolism.

Study details: Findings are from a safety analysis of the phase 3 monarchE study including 5591 patients with HR+/HER2-, node-positive, high-risk, early breast cancer who received ≥1 dose of abemaciclib+ET or ET alone in the adjuvant setting.

Disclosures: This study was supported by Eli Lilly and Company. Six authors declared being employees or shareholders of Eli Lilly and other authors reported ties with various sources, including Eli Lilly.

Source: Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 (Mar 22). Doi: 10.1016/j.annonc.2022.03.006

Key clinical point: Adjuvant abemaciclib plus endocrine therapy (ET) showed a manageable and acceptable safety profile in patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-), high-risk, early breast cancer breast cancer.

Major finding: Grade ≥3 adverse events (AE) were more frequent in the abemaciclib+ET vs. ET alone arm (49.7% vs. 16.3%); however, neutropenia, the most frequent grade ≥3 AE, was manageable with dose modification. The discontinuation of abemaciclib and abemaciclib+ET due to AE occurred in 18.5% and 6.5% of patients, respectively, with 66.8% discontinuing abemaciclib because of grade 1/2 AE and <1% because of neutropenia, increased transaminase, interstitial lung disease, or venous thromboembolism.

Study details: Findings are from a safety analysis of the phase 3 monarchE study including 5591 patients with HR+/HER2-, node-positive, high-risk, early breast cancer who received ≥1 dose of abemaciclib+ET or ET alone in the adjuvant setting.

Disclosures: This study was supported by Eli Lilly and Company. Six authors declared being employees or shareholders of Eli Lilly and other authors reported ties with various sources, including Eli Lilly.

Source: Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 (Mar 22). Doi: 10.1016/j.annonc.2022.03.006

Key clinical point: Neoadjuvant palbociclib plus endocrine therapy with letrozole and neoadjuvant chemotherapy demonstrated comparable survival outcomes in high-risk patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.

Major finding: In the neoadjuvant setting, the 3-year progression-free survival (hazard ratio [HR] 1.01; P = .98) and invasive disease-free survival (HR 0.83; P = .71) were not significantly different between the letrozole+palbociclib and chemotherapy groups.

Study details: Findings are from the phase 2 NeoPAL study including 106 postmenopausal women with ER+/HER2-, high-risk, early, luminal B or node-positive luminal A breast cancer who were randomly assigned to receive neoadjuvant letrozole+palbociclib or neoadjuvant chemotherapy.

Disclosures: This study was supported by the French Breast Cancer InterGroup-UNICANCER and Pfizer. Some authors declared serving on advisory boards or receiving funds, honoraria, fees, or personal support from various sources.

Source: Delaloge S et al. Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer. Eur J Cancer. 2022 (Mar 22). Doi: 10.1016/j.ejca.2022.01.014

Key clinical point: Neoadjuvant palbociclib plus endocrine therapy with letrozole and neoadjuvant chemotherapy demonstrated comparable survival outcomes in high-risk patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.

Major finding: In the neoadjuvant setting, the 3-year progression-free survival (hazard ratio [HR] 1.01; P = .98) and invasive disease-free survival (HR 0.83; P = .71) were not significantly different between the letrozole+palbociclib and chemotherapy groups.

Study details: Findings are from the phase 2 NeoPAL study including 106 postmenopausal women with ER+/HER2-, high-risk, early, luminal B or node-positive luminal A breast cancer who were randomly assigned to receive neoadjuvant letrozole+palbociclib or neoadjuvant chemotherapy.

Disclosures: This study was supported by the French Breast Cancer InterGroup-UNICANCER and Pfizer. Some authors declared serving on advisory boards or receiving funds, honoraria, fees, or personal support from various sources.

Source: Delaloge S et al. Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer. Eur J Cancer. 2022 (Mar 22). Doi: 10.1016/j.ejca.2022.01.014

Key clinical point: Neoadjuvant palbociclib plus endocrine therapy with letrozole and neoadjuvant chemotherapy demonstrated comparable survival outcomes in high-risk patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.

Major finding: In the neoadjuvant setting, the 3-year progression-free survival (hazard ratio [HR] 1.01; P = .98) and invasive disease-free survival (HR 0.83; P = .71) were not significantly different between the letrozole+palbociclib and chemotherapy groups.

Study details: Findings are from the phase 2 NeoPAL study including 106 postmenopausal women with ER+/HER2-, high-risk, early, luminal B or node-positive luminal A breast cancer who were randomly assigned to receive neoadjuvant letrozole+palbociclib or neoadjuvant chemotherapy.

Disclosures: This study was supported by the French Breast Cancer InterGroup-UNICANCER and Pfizer. Some authors declared serving on advisory boards or receiving funds, honoraria, fees, or personal support from various sources.

Source: Delaloge S et al. Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer. Eur J Cancer. 2022 (Mar 22). Doi: 10.1016/j.ejca.2022.01.014

Key clinical point: Ribociclib plus letrozole vs. letrozole alone prolonged overall survival (OS) by 12.5 months in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

Major finding: After a median follow-up of 80 months, ribociclib+letrozole showed significant survival benefit over placebo+letrozole (median overall survival 63.9 vs. 51.4 months; hazard ratio for death 0.76; 2-sided P = .008). No new safety signals were identified.

Study details: Findings are from the phase 3 MONALEESA-2 trial including 668 postmenopausal women with HR+/HER2- recurrent or metastatic breast cancer who had not received prior systemic therapy for advanced disease and were randomly assigned to receive first-line ribociclib or placebo, both with letrozole.

Disclosures: This study was funded by Novartis. Five authors declared being employees or stockholders of Novartis and others reported ties with various sources, including Novartis.

Source: Hortobagyi GN et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386:942-950 (Mar 10). Doi: 10.1056/NEJMoa2114663

Key clinical point: Ribociclib plus letrozole vs. letrozole alone prolonged overall survival (OS) by 12.5 months in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

Major finding: After a median follow-up of 80 months, ribociclib+letrozole showed significant survival benefit over placebo+letrozole (median overall survival 63.9 vs. 51.4 months; hazard ratio for death 0.76; 2-sided P = .008). No new safety signals were identified.

Study details: Findings are from the phase 3 MONALEESA-2 trial including 668 postmenopausal women with HR+/HER2- recurrent or metastatic breast cancer who had not received prior systemic therapy for advanced disease and were randomly assigned to receive first-line ribociclib or placebo, both with letrozole.

Disclosures: This study was funded by Novartis. Five authors declared being employees or stockholders of Novartis and others reported ties with various sources, including Novartis.

Source: Hortobagyi GN et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386:942-950 (Mar 10). Doi: 10.1056/NEJMoa2114663

Key clinical point: Ribociclib plus letrozole vs. letrozole alone prolonged overall survival (OS) by 12.5 months in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

Major finding: After a median follow-up of 80 months, ribociclib+letrozole showed significant survival benefit over placebo+letrozole (median overall survival 63.9 vs. 51.4 months; hazard ratio for death 0.76; 2-sided P = .008). No new safety signals were identified.

Study details: Findings are from the phase 3 MONALEESA-2 trial including 668 postmenopausal women with HR+/HER2- recurrent or metastatic breast cancer who had not received prior systemic therapy for advanced disease and were randomly assigned to receive first-line ribociclib or placebo, both with letrozole.

Disclosures: This study was funded by Novartis. Five authors declared being employees or stockholders of Novartis and others reported ties with various sources, including Novartis.

Source: Hortobagyi GN et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386:942-950 (Mar 10). Doi: 10.1056/NEJMoa2114663

Key clinical point: Trastuzumab deruxtecan was superior to trastuzumab emtansine in reducing the risk for disease progression or death in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer who had been previously treated with trastuzumab and a taxane.

Major finding: At 12 months, 75.8% of patients in the trastuzumab deruxtecan group vs. 34.1% patients in the trastuzumab emtansine group achieved progression-free survival (hazard ratio for disease progression/death from any cause 0.28; P < .001). The incidence of drug-related adverse events of any grade was 98.1% with trastuzumab deruxtecan and 86.6% with trastuzumab emtansine.

Study details: This interim analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic breast cancer who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed having taken trastuzumab and a taxane.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daichi Sankyo and one author declared being an employee of AstraZeneca. The other authors reported ties with various sources.

Source: Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386:1143-1154 (Mar 24). Doi: 10.1056/NEJMoa2115022

Key clinical point: Trastuzumab deruxtecan was superior to trastuzumab emtansine in reducing the risk for disease progression or death in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer who had been previously treated with trastuzumab and a taxane.

Major finding: At 12 months, 75.8% of patients in the trastuzumab deruxtecan group vs. 34.1% patients in the trastuzumab emtansine group achieved progression-free survival (hazard ratio for disease progression/death from any cause 0.28; P < .001). The incidence of drug-related adverse events of any grade was 98.1% with trastuzumab deruxtecan and 86.6% with trastuzumab emtansine.

Study details: This interim analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic breast cancer who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed having taken trastuzumab and a taxane.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daichi Sankyo and one author declared being an employee of AstraZeneca. The other authors reported ties with various sources.

Source: Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386:1143-1154 (Mar 24). Doi: 10.1056/NEJMoa2115022

Key clinical point: Trastuzumab deruxtecan was superior to trastuzumab emtansine in reducing the risk for disease progression or death in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer who had been previously treated with trastuzumab and a taxane.

Major finding: At 12 months, 75.8% of patients in the trastuzumab deruxtecan group vs. 34.1% patients in the trastuzumab emtansine group achieved progression-free survival (hazard ratio for disease progression/death from any cause 0.28; P < .001). The incidence of drug-related adverse events of any grade was 98.1% with trastuzumab deruxtecan and 86.6% with trastuzumab emtansine.

Study details: This interim analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic breast cancer who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed having taken trastuzumab and a taxane.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daichi Sankyo and one author declared being an employee of AstraZeneca. The other authors reported ties with various sources.

Source: Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386:1143-1154 (Mar 24). Doi: 10.1056/NEJMoa2115022

Key clinical point: Abrocitinib improved signs of atopic dermatitis (AD) rapidly and consistently in difficult-to-treat or cosmetically important anatomical regions, such as the head and neck area.

Major finding: Eczema Area and Severity Index (EASI) score of the head and neck region improved significantly as early as at 2 weeks with 200 mg abrocitinib (least square mean % change from baseline [Δ] 52.5%) and 100 mg abrocitinib (Δ 47.8%) vs. placebo (0.1%; both P < .0001) and improvements were sustained up to 16 weeks (both P ≤ .0002).

Study details: Findings are from a post hoc analysis of the phase 3 JADE COMPARE study including 837 patients with moderate-to-severe AD who were randomly assigned to receive 16 weeks of treatment with 200 mg abrocitinib, 100 mg abrocitinib, dupilumab, or placebo, all with background topical therapy.

Disclosures: This study was funded by Pfizer Inc. Five authors declared being current/former employees and shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.

Source: Alexis A et al. Rapidity of improvement in signs/symptoms of moderate-to-severe atopic dermatitis by body region with abrocitinib in the phase 3 JADE COMPARE study. Dermatol Ther (Heidelb). 2022;12:771-785 (Mar 17). Doi: 10.1007/s13555-022-00694-1

Key clinical point: Abrocitinib improved signs of atopic dermatitis (AD) rapidly and consistently in difficult-to-treat or cosmetically important anatomical regions, such as the head and neck area.

Major finding: Eczema Area and Severity Index (EASI) score of the head and neck region improved significantly as early as at 2 weeks with 200 mg abrocitinib (least square mean % change from baseline [Δ] 52.5%) and 100 mg abrocitinib (Δ 47.8%) vs. placebo (0.1%; both P < .0001) and improvements were sustained up to 16 weeks (both P ≤ .0002).

Study details: Findings are from a post hoc analysis of the phase 3 JADE COMPARE study including 837 patients with moderate-to-severe AD who were randomly assigned to receive 16 weeks of treatment with 200 mg abrocitinib, 100 mg abrocitinib, dupilumab, or placebo, all with background topical therapy.

Disclosures: This study was funded by Pfizer Inc. Five authors declared being current/former employees and shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.

Source: Alexis A et al. Rapidity of improvement in signs/symptoms of moderate-to-severe atopic dermatitis by body region with abrocitinib in the phase 3 JADE COMPARE study. Dermatol Ther (Heidelb). 2022;12:771-785 (Mar 17). Doi: 10.1007/s13555-022-00694-1

Key clinical point: Abrocitinib improved signs of atopic dermatitis (AD) rapidly and consistently in difficult-to-treat or cosmetically important anatomical regions, such as the head and neck area.

Major finding: Eczema Area and Severity Index (EASI) score of the head and neck region improved significantly as early as at 2 weeks with 200 mg abrocitinib (least square mean % change from baseline [Δ] 52.5%) and 100 mg abrocitinib (Δ 47.8%) vs. placebo (0.1%; both P < .0001) and improvements were sustained up to 16 weeks (both P ≤ .0002).

Study details: Findings are from a post hoc analysis of the phase 3 JADE COMPARE study including 837 patients with moderate-to-severe AD who were randomly assigned to receive 16 weeks of treatment with 200 mg abrocitinib, 100 mg abrocitinib, dupilumab, or placebo, all with background topical therapy.

Disclosures: This study was funded by Pfizer Inc. Five authors declared being current/former employees and shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.

Source: Alexis A et al. Rapidity of improvement in signs/symptoms of moderate-to-severe atopic dermatitis by body region with abrocitinib in the phase 3 JADE COMPARE study. Dermatol Ther (Heidelb). 2022;12:771-785 (Mar 17). Doi: 10.1007/s13555-022-00694-1

Key clinical point: Long-term dupilumab treatment reduced the severity of hand eczema (HE) and enhanced the quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 52, 87.1% patients achieved ≥75% improvement in Hand Eczema Severity Index score, 90.3% patients achieved “clear” or “almost clear” endpoint based on the photographic guide, and mean HE-specific Health-related QoL improved by 63.5% (95% CI −71.1% to −55.9%).

Study details: This was a prospective, observational study including 72 adults with moderate-to-severe AD and concomitant HE, of whom 62 patients completed the 52-week dupilumab treatment.

Disclosures: This study was supported by Sanofi and Regeneron Pharmaceuticals. MLA Schuttelaar and MS de Bruin-Welle declared serving as advisors, consultants, speakers, investigators, and advisory board members or receiving grants from several sources, including Regeneron and Sanofi Genzyme.

Source: Voorberg AN et al. The long-term effect of dupilumab on chronic hand eczema in patients with moderate to severe atopic dermatitis – 52 week results from the Dutch BioDay registry. Contact Dermatitis. 2022 (Mar 13). Doi: 10.1111/cod.14104

Key clinical point: Long-term dupilumab treatment reduced the severity of hand eczema (HE) and enhanced the quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 52, 87.1% patients achieved ≥75% improvement in Hand Eczema Severity Index score, 90.3% patients achieved “clear” or “almost clear” endpoint based on the photographic guide, and mean HE-specific Health-related QoL improved by 63.5% (95% CI −71.1% to −55.9%).

Study details: This was a prospective, observational study including 72 adults with moderate-to-severe AD and concomitant HE, of whom 62 patients completed the 52-week dupilumab treatment.

Disclosures: This study was supported by Sanofi and Regeneron Pharmaceuticals. MLA Schuttelaar and MS de Bruin-Welle declared serving as advisors, consultants, speakers, investigators, and advisory board members or receiving grants from several sources, including Regeneron and Sanofi Genzyme.

Source: Voorberg AN et al. The long-term effect of dupilumab on chronic hand eczema in patients with moderate to severe atopic dermatitis – 52 week results from the Dutch BioDay registry. Contact Dermatitis. 2022 (Mar 13). Doi: 10.1111/cod.14104

Key clinical point: Long-term dupilumab treatment reduced the severity of hand eczema (HE) and enhanced the quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 52, 87.1% patients achieved ≥75% improvement in Hand Eczema Severity Index score, 90.3% patients achieved “clear” or “almost clear” endpoint based on the photographic guide, and mean HE-specific Health-related QoL improved by 63.5% (95% CI −71.1% to −55.9%).

Study details: This was a prospective, observational study including 72 adults with moderate-to-severe AD and concomitant HE, of whom 62 patients completed the 52-week dupilumab treatment.

Disclosures: This study was supported by Sanofi and Regeneron Pharmaceuticals. MLA Schuttelaar and MS de Bruin-Welle declared serving as advisors, consultants, speakers, investigators, and advisory board members or receiving grants from several sources, including Regeneron and Sanofi Genzyme.

Source: Voorberg AN et al. The long-term effect of dupilumab on chronic hand eczema in patients with moderate to severe atopic dermatitis – 52 week results from the Dutch BioDay registry. Contact Dermatitis. 2022 (Mar 13). Doi: 10.1111/cod.14104

Key clinical point: Under maximum use conditions, ruxolitinib cream was well-tolerated and reduced the severity of atopic dermatitis (AD) in patients with ≥25% body surface area (BSA) involvement.

Major finding: Treatment-emergent adverse events (AE) of mostly mild and moderate intensity and treatment-related AE were reported by 31.7% and 9.8% of patients, respectively. At day 56, 94.6% of patients reported ≥75% improvement in the Eczema Area and Severity Index.

Study details: Findings are from the phase 1 maximum-use trial including 41 patients with AD who had ≥25% BSA involvement and were administered 1.5% ruxolitinib cream twice daily for 28 days. Of these, 37 patients did not experience any safety concerns and continued treatment for an additional 28 days.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation and other authors reported ties with several sources.

Source: Bissonnette R et al. A maximum-use trial of ruxolitinib cream in adolescents and adults with atopic dermatitis. Am J Clin Dermatol. 2022 (Apr 4). Doi: 10.1007/s40257-022-00690-3

Key clinical point: Under maximum use conditions, ruxolitinib cream was well-tolerated and reduced the severity of atopic dermatitis (AD) in patients with ≥25% body surface area (BSA) involvement.

Major finding: Treatment-emergent adverse events (AE) of mostly mild and moderate intensity and treatment-related AE were reported by 31.7% and 9.8% of patients, respectively. At day 56, 94.6% of patients reported ≥75% improvement in the Eczema Area and Severity Index.

Study details: Findings are from the phase 1 maximum-use trial including 41 patients with AD who had ≥25% BSA involvement and were administered 1.5% ruxolitinib cream twice daily for 28 days. Of these, 37 patients did not experience any safety concerns and continued treatment for an additional 28 days.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation and other authors reported ties with several sources.

Source: Bissonnette R et al. A maximum-use trial of ruxolitinib cream in adolescents and adults with atopic dermatitis. Am J Clin Dermatol. 2022 (Apr 4). Doi: 10.1007/s40257-022-00690-3

Key clinical point: Under maximum use conditions, ruxolitinib cream was well-tolerated and reduced the severity of atopic dermatitis (AD) in patients with ≥25% body surface area (BSA) involvement.

Major finding: Treatment-emergent adverse events (AE) of mostly mild and moderate intensity and treatment-related AE were reported by 31.7% and 9.8% of patients, respectively. At day 56, 94.6% of patients reported ≥75% improvement in the Eczema Area and Severity Index.

Study details: Findings are from the phase 1 maximum-use trial including 41 patients with AD who had ≥25% BSA involvement and were administered 1.5% ruxolitinib cream twice daily for 28 days. Of these, 37 patients did not experience any safety concerns and continued treatment for an additional 28 days.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation and other authors reported ties with several sources.

Source: Bissonnette R et al. A maximum-use trial of ruxolitinib cream in adolescents and adults with atopic dermatitis. Am J Clin Dermatol. 2022 (Apr 4). Doi: 10.1007/s40257-022-00690-3

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), baricitinib therapy resulted in rapid and sustained improvement in skin pain leading to an enhanced quality of life (QoL).

Major finding: Skin pain improved as early as by day 1 with 2 mg baricitinib (least square mean % change from baseline [Δ] −4.4%; P = .048) and by day 2 with 1 mg baricitinib (Δ −6.7%; P = .011) vs. placebo, with improvements maintained through week 16 for both baricitinib doses (P ≤ .05) and 70.9% vs. 10.4% of skin pain responders vs. nonresponders experiencing clinically meaningful improvement in QoL (P < .0001).

Study details: Findings are from a post hoc analysis of the phase 3 BREEZE-AD5 study including 440 adults with moderate-to-severe AD and inadequate response to topical therapy who were randomly assigned to receive once-daily 1 mg baricitinib, 2 mg baricitinib, or placebo for 16 weeks.

Disclosures: This study was sponsored by Eli Lilly and Company. Three authors declared being employees and shareholders of Eli Lilly and other authors reported ties with several sources, including Eli Lilly.

Source: Rosmarin D et al. Rapid improvement in skin pain severity and its impact on quality of life in adult patients with moderate-to-severe atopic dermatitis from a double-blind, placebo-controlled baricitinib phase 3 study. J Cutan Med Surg. 2022 (Mar 31). Doi: 10.1177/12034754221088542

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), baricitinib therapy resulted in rapid and sustained improvement in skin pain leading to an enhanced quality of life (QoL).

Major finding: Skin pain improved as early as by day 1 with 2 mg baricitinib (least square mean % change from baseline [Δ] −4.4%; P = .048) and by day 2 with 1 mg baricitinib (Δ −6.7%; P = .011) vs. placebo, with improvements maintained through week 16 for both baricitinib doses (P ≤ .05) and 70.9% vs. 10.4% of skin pain responders vs. nonresponders experiencing clinically meaningful improvement in QoL (P < .0001).

Study details: Findings are from a post hoc analysis of the phase 3 BREEZE-AD5 study including 440 adults with moderate-to-severe AD and inadequate response to topical therapy who were randomly assigned to receive once-daily 1 mg baricitinib, 2 mg baricitinib, or placebo for 16 weeks.

Disclosures: This study was sponsored by Eli Lilly and Company. Three authors declared being employees and shareholders of Eli Lilly and other authors reported ties with several sources, including Eli Lilly.

Source: Rosmarin D et al. Rapid improvement in skin pain severity and its impact on quality of life in adult patients with moderate-to-severe atopic dermatitis from a double-blind, placebo-controlled baricitinib phase 3 study. J Cutan Med Surg. 2022 (Mar 31). Doi: 10.1177/12034754221088542

Key clinical point: In patients with moderate-to-severe atopic dermatitis (AD), baricitinib therapy resulted in rapid and sustained improvement in skin pain leading to an enhanced quality of life (QoL).

Major finding: Skin pain improved as early as by day 1 with 2 mg baricitinib (least square mean % change from baseline [Δ] −4.4%; P = .048) and by day 2 with 1 mg baricitinib (Δ −6.7%; P = .011) vs. placebo, with improvements maintained through week 16 for both baricitinib doses (P ≤ .05) and 70.9% vs. 10.4% of skin pain responders vs. nonresponders experiencing clinically meaningful improvement in QoL (P < .0001).

Study details: Findings are from a post hoc analysis of the phase 3 BREEZE-AD5 study including 440 adults with moderate-to-severe AD and inadequate response to topical therapy who were randomly assigned to receive once-daily 1 mg baricitinib, 2 mg baricitinib, or placebo for 16 weeks.

Disclosures: This study was sponsored by Eli Lilly and Company. Three authors declared being employees and shareholders of Eli Lilly and other authors reported ties with several sources, including Eli Lilly.

Source: Rosmarin D et al. Rapid improvement in skin pain severity and its impact on quality of life in adult patients with moderate-to-severe atopic dermatitis from a double-blind, placebo-controlled baricitinib phase 3 study. J Cutan Med Surg. 2022 (Mar 31). Doi: 10.1177/12034754221088542

Key clinical point: Children born to mothers who had a cumulative exposure to psychological distress in the prenatal and postnatal periods were at an increased risk of developing atopic dermatitis (AD) at 1-2 years of age.

Major finding: Maternal psychological distress vs. no psychological distress in both prenatal and postnatal periods (adjusted relative risk [RR] 1.34; 95% CI 1.20-1.47) and only in the postnatal period (adjusted RR 1.23; 95% CI 1.07-1.39) was significantly associated with an increased risk of developing AD in children at 1-2 years of age.

Study details: This study analyzed maternal psychological distress during early pregnancy and 1 year after delivery in 8377 mother-child pairs, wherein the child had not developed AD by the age of 1 year.

Disclosures: This study was supported by the Ministry of Education, Culture, Sports, Science, and Technology, Japan. K Murakami declared being an editorial board member of BMC Public Health.

Source: Kawaguchi C et al. Cumulative exposure to maternal psychological distress in the prenatal and postnatal periods and atopic dermatitis in children: Findings from the TMM BirThree Cohort Study. BMC Pregnancy Childbirth. 2022;22:242 (Mar 24). Doi: 10.1186/s12884-022-04556-8

Key clinical point: Children born to mothers who had a cumulative exposure to psychological distress in the prenatal and postnatal periods were at an increased risk of developing atopic dermatitis (AD) at 1-2 years of age.

Major finding: Maternal psychological distress vs. no psychological distress in both prenatal and postnatal periods (adjusted relative risk [RR] 1.34; 95% CI 1.20-1.47) and only in the postnatal period (adjusted RR 1.23; 95% CI 1.07-1.39) was significantly associated with an increased risk of developing AD in children at 1-2 years of age.

Study details: This study analyzed maternal psychological distress during early pregnancy and 1 year after delivery in 8377 mother-child pairs, wherein the child had not developed AD by the age of 1 year.

Disclosures: This study was supported by the Ministry of Education, Culture, Sports, Science, and Technology, Japan. K Murakami declared being an editorial board member of BMC Public Health.

Source: Kawaguchi C et al. Cumulative exposure to maternal psychological distress in the prenatal and postnatal periods and atopic dermatitis in children: Findings from the TMM BirThree Cohort Study. BMC Pregnancy Childbirth. 2022;22:242 (Mar 24). Doi: 10.1186/s12884-022-04556-8

Key clinical point: Children born to mothers who had a cumulative exposure to psychological distress in the prenatal and postnatal periods were at an increased risk of developing atopic dermatitis (AD) at 1-2 years of age.

Major finding: Maternal psychological distress vs. no psychological distress in both prenatal and postnatal periods (adjusted relative risk [RR] 1.34; 95% CI 1.20-1.47) and only in the postnatal period (adjusted RR 1.23; 95% CI 1.07-1.39) was significantly associated with an increased risk of developing AD in children at 1-2 years of age.

Study details: This study analyzed maternal psychological distress during early pregnancy and 1 year after delivery in 8377 mother-child pairs, wherein the child had not developed AD by the age of 1 year.

Disclosures: This study was supported by the Ministry of Education, Culture, Sports, Science, and Technology, Japan. K Murakami declared being an editorial board member of BMC Public Health.

Source: Kawaguchi C et al. Cumulative exposure to maternal psychological distress in the prenatal and postnatal periods and atopic dermatitis in children: Findings from the TMM BirThree Cohort Study. BMC Pregnancy Childbirth. 2022;22:242 (Mar 24). Doi: 10.1186/s12884-022-04556-8

Key clinical point: Patients with chronic rhinosinusitis (CRS) were more likely to develop atopic dermatitis (AD), particularly young (<45 years) and middle-aged (45-64 years) patients.

Major finding: The risk of developing AD was significantly higher in patients with vs. without CRS (adjusted hazard ratio [aHR] 1.1952; 95% CI 1.1009-1.2976), especially among young (aHR 1.1491; 95% CI 1.0386-1.2713) and middle-aged (aHR 1.2944; 95% CI 1.1044-1.5171) patients.

Study details: This was a longitudinal cohort study that included 16,668 patients with CRS and 33,336 sociodemographically matched control individuals without CRS who were followed-up for 11 years.

Disclosures: This research was supported by Hallym University Research Fund and the National Research Foundation funded by the Korean government. The authors declared no conflicts of interest.

Source: Son D-S et al. Chronic rhinosinusitis and the increased incidence of atopic dermatitis. Am J Rhinol Allergy. 2022 (Mar 29). Doi: 10.1177/19458924221090050

Key clinical point: Patients with chronic rhinosinusitis (CRS) were more likely to develop atopic dermatitis (AD), particularly young (<45 years) and middle-aged (45-64 years) patients.

Major finding: The risk of developing AD was significantly higher in patients with vs. without CRS (adjusted hazard ratio [aHR] 1.1952; 95% CI 1.1009-1.2976), especially among young (aHR 1.1491; 95% CI 1.0386-1.2713) and middle-aged (aHR 1.2944; 95% CI 1.1044-1.5171) patients.

Study details: This was a longitudinal cohort study that included 16,668 patients with CRS and 33,336 sociodemographically matched control individuals without CRS who were followed-up for 11 years.

Disclosures: This research was supported by Hallym University Research Fund and the National Research Foundation funded by the Korean government. The authors declared no conflicts of interest.

Source: Son D-S et al. Chronic rhinosinusitis and the increased incidence of atopic dermatitis. Am J Rhinol Allergy. 2022 (Mar 29). Doi: 10.1177/19458924221090050

Key clinical point: Patients with chronic rhinosinusitis (CRS) were more likely to develop atopic dermatitis (AD), particularly young (<45 years) and middle-aged (45-64 years) patients.

Major finding: The risk of developing AD was significantly higher in patients with vs. without CRS (adjusted hazard ratio [aHR] 1.1952; 95% CI 1.1009-1.2976), especially among young (aHR 1.1491; 95% CI 1.0386-1.2713) and middle-aged (aHR 1.2944; 95% CI 1.1044-1.5171) patients.

Study details: This was a longitudinal cohort study that included 16,668 patients with CRS and 33,336 sociodemographically matched control individuals without CRS who were followed-up for 11 years.

Disclosures: This research was supported by Hallym University Research Fund and the National Research Foundation funded by the Korean government. The authors declared no conflicts of interest.

Source: Son D-S et al. Chronic rhinosinusitis and the increased incidence of atopic dermatitis. Am J Rhinol Allergy. 2022 (Mar 29). Doi: 10.1177/19458924221090050